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Medical Waste


Definition of Medical Waste
OSHA Regulations
Contact

 


Medical Waste Definition

(a) “Medical waste” means any biohazardous, pathology, pharmaceutical, or trace chemotherapy waste not regulated by the federal Resource Conservation and Recovery Act of 1976 (Public Law 94-580), as amended; sharps and trace chemotherapy wastes generated in a health care setting in the diagnosis, treatment, immunization, or care of humans or animals; waste generated in autopsy or necropsy; waste generated during preparation of a body for final disposition such as cremation or interment; waste generated in research pertaining to the production or testing of microbiologicals; waste generated in research using human or animal pathogens; sharps and laboratory waste that poses a potential risk of infection to humans generated in the inoculation of animals in commercial farming operations; waste generated from the consolidation of home- generated sharps; and waste generated in the cleanup of trauma scenes. Biohazardous, pathology, pharmaceutical, sharps, and trace chemotherapy wastes that meet the conditions of this section are not subject to any of the hazardous waste requirements found in Chapter 6.5 (commencing with Section 25100) of Division 20.
(b) For purposes of this part the following definitions apply:

(1) “Biohazardous waste” includes all of the following:

  • (A)(i) Regulated medical waste, clinical waste, or biomedical waste that is a waste or reusable material derived from the medical treatment of a human or from an animal that is suspected by the attending veterinarian of being infected with a pathogen that is also infectious to humans, which includes diagnosis and immunization; or from biomedical research, which includes the production and testing of biological products.
    (ii) Regulated medical waste or clinical waste or biomedical waste suspected of containing a highly communicable disease.
  • (B) Laboratory waste such as human specimen cultures or animal specimen cultures that are infected with pathogens that are also infectious to humans; cultures and stocks of infectious agents from research; wastes from the production of bacteria, viruses, spores, discarded live and attenuated vaccines used in human health care or research, discarded animal vaccines, including Brucellosis and Contagious Ecthyma, as defined by the department; culture dishes, devices used to transfer, inoculate, and mix cultures; and wastes identified by Section 173.134 of Title 49 of the Code of Federal Regulations as Category B “once wasted” for laboratory wastes.
  • (C) Waste that, at the point of transport from the generator’s site or at the point of disposal contains recognizable fluid human blood, fluid human blood products, containers, or equipment containing human blood that is fluid, or blood from animals suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans.
  • (D) Waste containing discarded materials contaminated with excretion, exudate, or secretions from humans or animals that are required to be isolated by the infection control staff, the attending physician and surgeon, the attending veterinarian, or the local health officer, to protect others from highly communicable diseases or diseases of animals that are communicable to humans.

(2) Pathology waste includes both of the following:

(A) Human body parts, with the exception of teeth, removed at surgery and surgery specimens or tissues removed at surgery or autopsy that are suspected by the health care professional of being contaminated with infectious agents known to be contagious to humans or having been fixed in formaldehyde or another fixative.
(B) Animal parts, tissues, fluids, or carcasses suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans.

(3) “Pharmaceutical waste” means a pharmaceutical, as defined in Section 117747, including trace chemotherapy waste, that is a waste, as defined in Section 25124. For purposes of this part, “pharmaceutical waste” does not include a pharmaceutical that meets either of the following criteria:

  • (A) The pharmaceutical is being sent out of the state to a reverse distributor, as defined in Section 4040.5 of the Business and Professions Code, that is licensed as a wholesaler of dangerous drugs by the California State Board of Pharmacy pursuant to Section 4161 of the Business and Professions Code.
  • (B) The pharmaceutical is being sent by a reverse distributor, as defined in Section 4040.5 of the Business and Professions Code, offsite for treatment and disposal in accordance with applicable laws, or to a reverse distributor that is licensed as a wholesaler of dangerous drugs by the California State Board of Pharmacy pursuant to Section 4160 of the Business and Professions Code and as a permitted transfer station if the reverse distributor is located within the state.

(4) “Sharps waste” means a device that has acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, hypodermic needles, hypodermic needles with syringes, blades, needles with attached tubing, acupuncture needles, root canal files, broken glass items used in health care such as Pasteur pipettes and blood vials contaminated with biohazardous waste, and any item capable of cutting or piercing from trauma scene waste.

(5) “Trace chemotherapeutic waste” means waste that is contaminated through contact with, or having previously contained, chemotherapeutic agents, including, but not limited to, gloves, disposable gowns, towels, and intravenous solution bags and attached tubing that are empty. A biohazardous waste that meets the conditions of this paragraph is not subject to the hazardous waste requirements of Chapter 6.5 (commencing with Section 25100) of Division 20.

(6) “Trauma scene waste” means waste that is a regulated waste, as defined in Section 5193 of Title 8 of the California Code of Regulations, and that has been removed, is to be removed, or is in the process of being removed, from a trauma scene by a trauma scene waste management practitioner.

Large vs. Small Waste Generators

The Medical Waste Management Act (MWMA) considers any person whose act or process produces medical waste to be a “medical waste generator” in California (e.g. a facility or business that generates, and/or stores medical waste onsite).  Medical waste generators may be either:

  • large quantity generators (LQG = >200lbs/month), or
  • small quantity generators (SQG = <200lbs/month).

Registration

Medical waste generators must register with their enforcement agency (click here for a list of Local Enforcement Agencies ).

Medical waste generators, whether large quantity generators or small quantity generators, located in counties where the state acts as the local enforcement agency (see the CA state map link above to determine the enforcement agency in each county) must complete the Generator Registration Application (see below) and mail it along with the fee page (below) to the address provided. For those medical waste generators treating medical waste on-site, an on-site treatment permit application must also be completed and submitted. Each application, along with a check made payable to the Medical Waste Management Fund must be mailed to:

California Department of Health Services
Medical Waste Management Program
P.O. Box 997413, MS 7405
Sacramento, CA 95899-7413

  • DHS form # 8550 ­ Generator Registration Application 
  • DHS form # 8662 ­ Current Fees
  • DHS form # 8667--Medical Waste Facility Permit Application

Management Plan

LQG's or SQG with on-site treatment are required to submit a Medical Waste Management Plan (Plan) with their medical waste enforcement agency.  A Plan Checklist is provided to assist medical waste generators in developing their Plan.

  • DHS form #8661 ­ Medical Waste Management Plan Checklist 

Segregation and Storage

Rules for containerizing and storing medical waste vary depending or the type of waste.  The following rules apply (for complete rules see Chapter 9 of the Medical Waste Management Act, below):

  • Medical waste must be contained separately from other waste at the point of origin in the healthcare facility.  Sharps containers may be placed in biohazard bags or in containers with biohazard bags.
  • Biohazardous waste must be placed in a red biohazard bag conspicuously labeled with the words “Biohazardous Waste” or with the international biohazard symbol and the word “BIOHAZARD.”
  • Sharps waste must be contained in a sharps container.
  • Biohazardous waste that is contaminated through contact with, or having previously contained, chemo-therapeutic agents, must be segregated for storage, and, when placed in a secondary container, that container must be labeled with the words “Chemotherapy Waste”, “CHEMO”, or other label approved by the department on the lid and on the sides, so as to be visible from any lateral direction.
  • Biohazardous waste comprised of human surgery specimens or tissues which have been fixed in formaldehyde or other fixatives, must be segregated for storage and, when placed in a secondary container, that container must be labeled with the words “Pathology Waste”, “ PATH”, or other label approved by the department on the lid and on the sides, so as to be visible from any lateral direction.

To containerize biohazard bags, a person must do all of the following:

  • The bags must be tied to prevent leakage or expulsion of contents during all future storage, handling, or transport.
  • Biohazardous waste must be appropriately bagged and placed for storage, handling, or transport in a rigid container which may be disposable, reusable, or recyclable.
  • Containers must be leak resistant, have tight-fitting covers, and be kept clean and in good repair. 
  • Containers may be of any color and must be labeled with the words “Biohazardous Waste” or with the international biohazard symbol and the word “BIOHAZARD” on the lid and on the sides so as to be visible from any lateral direction.
  • Biohazardous waste must not be removed from the biohazard bag until treatment is completed.
  • Biohazardous waste must not be disposed of before being treated.
  • If a facility generates 20 or more pounds of biohazardous waste per month, the facility must not contain or store biohazardous or sharps waste above 0 degrees Centigrade (32 degrees Fahrenheit) at any onsite location for more than seven days without obtaining prior written approval of the enforcement agency.
  • If a facility generates less than 20 pounds of biohazardous waste per month, the person must not contain or store biohazardous waste above 0 degrees Centigrade (32 degrees Fahrenheit) at any onsite location for more than 30 days.
  • A facility may store biohazardous or sharps waste at or below 0 degrees Centigrade (32 degrees Fahrenheit) at an onsite location for not more than 90 days without obtaining prior written approval of the enforcement agency.
  • A facility may store biohazardous or sharps waste at a permitted transfer station at or below 0 degrees Centigrade (32 degrees Fahrenheit) for not more than 30 days without obtaining prior written approval of the enforcement agency.
  • A facility must not store biohazardous or sharps waste above 0 degrees Centigrade (32 degrees Fahrenheit) at any location or facility which is offsite from the generator for more than seven days before treatment.

To containerize sharps waste, a facility must do all of the following:

  • Place all sharps waste into a sharps container.
  • Tape closed or tightly lid full sharps containers ready for disposal to preclude loss of contents.
  • Store sharps containers ready for disposal for not more than seven days.
  • Label sharps containers with the words “sharps waste” or with the international biohazard symbol and the word “BIOHAZARD”.

Treatment of Medical Waste

A person generating or treating medical waste shall ensure that the medical waste is treated by one of the following methods, thereby rendering it solid waste prior to disposal:

  • Incineration at a permitted medical waste treatment facility in a controlled-air, multi-chamber incinerator, or other method of incineration approved by the department which provides complete combustion of the waste into carbonized or mineralized ash.
  • Treatment with an approved alternative technology that, due to the extremely high temperatures of treatment in excess of 1300 degrees Fahrenheit, has received express approval from the department.
  • Steam sterilization at a permitted medical waste treatment facility or by other sterilization, in accordance with all approved operating procedures for steam sterilizers or other sterilization
  • Other alternative medical waste treatment methods which are approved by the department and result in the destruction of pathogenic micro-organisms.

Disposal of Medical Waste

  • A medical waste may be discharged to a public sewage system without treatment if it is not a biohazardous waste, it is liquid or semiliquid, and its discharge is consistent with waste discharge requirements placed on the public sewage system by the California regional water quality control board with jurisdiction.
  • A medical waste that is a biohazardous waste may be treated by a chemical disinfection if the medical waste is liquid or semi-liquid and the chemical disinfection method is recognized by the National Institutes of Health, the Centers for Disease Control and Prevention, or the American Biological Safety Association, and if the use of chemical disinfection as a treatment method is identified in the site’s medical waste management plan. If the waste is not treated by chemical disinfection, it shall treated by one of the other approved methods. Following treatment by chemical disinfection, medical waste may be discharged to the public sewage system if the discharge is consistent with waste discharge requirements placed on the public sewage system by the California regional water control board, and the discharge is in compliance with the requirements imposed by the owner or operator of the public sewage system. If the chemical disinfection of the medical waste causes the waste to become a hazardous waste, the waste shall be managed in accordance with applicable requirements
  • Recognizable human anatomical parts, with the exception of teeth not deemed infectious by the attending physician and surgeon or dentist, shall be disposed of by interment or in accordance with the regulations, unless otherwise hazardous.
  • Sharps waste shall be rendered noninfectious prior to disposal by Incineration; steam sterilization; or disinfection, using an alternative treatment method approved by the department. Sharps waste rendered noninfectious may be disposed of as solid waste if the waste is not otherwise hazardous.
  • Onsite medical waste treatment facilities treating sharps waste shall ensure that, prior to disposal, the treated sharps waste is destroyed or that public access to the treated sharps waste is prevented.
  • An operator of a permitted hazardous waste incinerator may also accept medical waste for incineration.
  • Each medical waste treatment facility issued a medical waste permit shall provide the enforcement agency with an emergency action plan that the facility shall follow to ensure the proper disposal of medical waste in the event of equipment breakdowns, natural disasters, or other occurrences.
  • Animals that die from infectious diseases shall be treated in accordance with the regulations, if, in the opinion of the attending veterinarian or local health officer, the carcass presents a danger of infection to humans.

Waste Tracking Documents

Tracking documents are provided to the generator by the transporter.  Medical waste generators are required to maintain a completed tracking document of all medical waste removed for treatment or disposal for a period of three years.

Contacts

For more information on Medical Waste Management Program activities contact either the Medical Waste Management Program HQ at (818) 551-2042, or the Southern California Regional Office at (818) 551-2040 or (818) 551-2041.

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  California is one of 24 states operating an approved occupational safety and health program.  This program is operated by Cal/OSHA.  OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Regulations

The Medical Waste Management Act (MWMA) governs the management of medical waste in all jurisdictions of the State.

Additional Resources

Main RMW Page

RMW Generator Page

RMW Local Enforcement Agencies

Medical Waste Management Act

©2015 Healthcare Environmental Resource Center
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